EVI SUTURED-CLIP APPLIER— 510(k) K971588

Name: FDA 510(k) clearance K971588
Creator: U.S. Food and Drug Administration
Published: 1997-10-24

Substantially Equivalent

Elective Vascular Intervention Inc. (Evi)

FDA 510(k) clearance K971588 for EVI SUTURED-CLIP APPLIER, Substantially Equivalent on 1997-10-24. Applicant: Elective Vascular Intervention Inc. (Evi). Device class: 2.

Clearance details

Applicant: Elective Vascular Intervention Inc. (Evi)
Product code: Code FZP
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 1997-05-01
Decision date: 1997-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZP

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K253903 — InnoClip Disposable Clip Applier2025-12-22
K250643 — Disposable Polymer Ligation Clips2025-11-20
K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips2025-07-03

Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.